What happened to Hydroquinone?

Hydroquinone, commonly used as a skin-lightening agent, decreases the number of melanocytes present to minimize the appearance of hyperpigmentation. Although it is a popular buzz ingredient, everyday consumers and professionals in the aesthetics industry may have started to wonder what happened to hydroquinone and why it has virtually disappeared from the U.S. market. “Will it ever come back?” “Why was it banned in the first place?” “What was the reason?!”

Up until recently, hydroquinone was available over-the-counter (OTC) in a 2% concentration without the need for a prescription. However, with no prior notice or widely published announcement, several OTC drugs that were pending a final monograph (rule book covering conditions for active ingredients) from the FDA were removed from the market through the passage of the CARES Act (The Coronavirus Aid, Relief, and Economic Security). Due to the new regulations, hydroquinone has not been officially found to be GRASE (generally regarded as safe and effective) by the FDA.2 The ban in the US follows prior bans in other parts of the world like Japan, Australia, and Europe1, leaving many consumers confused and unhappy worldwide.

Is Hydroquinone dangerous?

Understandably, consumers may be confused or worried about the seemingly abrupt removal of hydroquinone from the shelves. The answer is that per FDA, hydroquinone had not been deemed dangerous or proven to be a cause of health concerns for users. However, without a final monograph in place, hydroquinone has been downgraded as not GRASE. There is a specific process that a drug must go through to be identified as GRASE.3

Until this process is complete, it is marked as a new drug, even if it has a long history of safe and effective use, as is the case with low concentrations of hydroquinone. Once approved, hydroquinone may make its way back into the market.1

But how does this tie into the CARES Act? Believe it or not, hydroquinone has nothing to do with the coronavirus and more to do with convenience. The CARES Act included the OTC drug monograph reform act which pulled old data on hydroquinone in rats, and that initiated the ban of the drug.2 The issue of banning hydroquinone has always been on the table since 2006, and it wasn’t until now that the CARES Act decided to ban OTC drugs as part of the legislation.2

How will this affect consumers?

Unless it is prescribed by a doctor, hydroquinone is not directly accessible to consumers. Due to the change in availability and uncertain future of OTC hydroquinone products, consumers are immediately affected by this new legislation. Consumers who rely on hydroquinone to treat skin conditions such as hyperpigmentation, melasma, and sun damage have to find alternative agents with comparable efficacy.

Sadly, this ban ends up directly penalizing consumers for no good reason. According to an online skin-care retailer, the journey to get these products back on the shelves is an uphill battle.2 The higher the demand, the higher the cost. Consumers who are reliant on hydroquinone will be impacted the most as well as companies who wish to integrate hydroquinone into their products. Brands would have to go through extensive clinical trials which can be very expensive.2

Good news

Although hydroquinone is no longer available as an OTC, it is still available with a prescription. However, we do understand the cost and inconvenience associated with having to get a prescription from a doctor. CRL is committed to upholding the highest standards of quality to deliver the safest and most effective products. In the meantime, we would like to recommend some gentle yet effective alternatives.